A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy | Completed
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
ANDANTE
Trial Source

There is no location for this trial

Location data is sourced from multiple external providers and UKCTG is not responsible for and cannot guarantee the accuracy of data.

Health Conditions
  • Crohn's Disease
Unfortunately contact details are not available for this trial.
Primary Contact Details
Completed
Recruitment Status
NCT01287897
Primary Trial ID Number
Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Research Details
    Sorry, this information is not available
Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Study Type
Interventional
Intervention
Drug : PF-04236921 SC injection, Drug : PF-04236921 SC injection, Drug : PF-04236921 SC injection

Study Arm Groups : Placebo- SC injection, Drug Dose level 1 - SC injection, Drug Dose level 2 - SC injection

Intervention Type
See Interventions above
Primary Outcome Measures
  • The Crohn's Disease Activity Index (CDAI) 70 response rate at Week 8 or Week 12; Baseline, Weeks 2, 4, 6, 8, 10 and 12
Secondary Outcome Measures
  • Percent of subjects with a CDAI remission (CDAI <150), CDAI 70 and CDAI 100 responses; Weeks 2 through 12; Mean change from baseline for CDAI score; Weeks 2 through 12; Percent of subjects that develop anti drug antibodies (ADAs) and neutralizing antibodies (NAbs), if observed; baseline, and Weeks 4, 8, 12, 16, 24, 32 and 40; Serum concentrations of PF 04236921; Baseline, Weeks 2, 4, 6, 8, 10 and Week 12 and monthly through Week 40
Publication(s)
Sorry, this information is not available
Result Reports
This is available on the Clinicaltrials.gov website
Gender
Both
Age Range
18 Years - 75 Years
Who Can Participate
Patients
Number of Participants
Sorry, this information is not available
Participant Inclusion Criteria
  • Inclusion Criteria:
  • - Subjects must have failed or are intolerant to anti TNFs
  • - hsCRP greater or equal to 5.0 mg/L
  • - Ulcerations demonstrated by colonoscopy as defined by SES CD assessment performed
  • within 8 weeks of study entry (screening) and able to retrospectively complete the
  • SES-CD or colonoscopy performed during screening
  • Exclusion Criteria:
  • - Pregnant or breastfeeding women
  • - Crohn's Disease with active fistulae or abscess
  • - History of diverticulitis or symptomatic diverticulosis
  • - Abnormality in hematology or chemistry profiles at screening
Participant Exclusion Criteria
This is in the inclusion criteria above
Trial Location(s)
Research Site
Hull
HU3 2JZ
London
NW3 2QG
Pfizer Investigational Site
London
E1 1BB
GSK Investigational Site
Glasgow
G11 6NT
Addenbrookes Hospital
Cambridge
CB2 0QQ
New Cross Hospital
Wolverhampton
Midlands
WV10 0QP
Royal Victoria Infirmary
Newcastle-Upon-Tyne
England
NE1 4LP
Glasgow Royal Infirmary
Glasgow
G40SS
Glasgow Clinical Research Facility
Glasgow
G33 2ER
Pharmacy Department
Glasgow
G3 0SF
Trial Contact(s)
Primary Trial Contact
Sorry, this information is not available
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United States, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Hungary, Ireland, Israel, Italy, New Zealand, Romania, Switzerland, United Kingdom
Scientific Title
A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-04236921 In Subjects With Crohn's Disease Who Are Anti-tnf Inadequate Responders (Andante)
EudraCT Number
Not available for this trial
Funder(s)
    Sorry, this information is not available
Other Study ID Numbers
B0151003
Sponsor(s)
Pfizer
Key Dates

Recruitment Start Date

Feb 2011

Recruitment End Date

Sep 2014

Trial Start Date
Date Not Available
Trial End Date
Date Not Available
Date Assigned

31 Jan 2011

Last Updated

20 Apr 2015